LXXGF - LexaGene advances towards FDA emergency use nod for MiQLab System

LexaGene Holdings (LXXGF) announces that it continues to systematically advance the MiQLab System to meet the FDA criteria for Emergency Use Authorization ((EUA)).The MiQLab System is a first of its kind, point of care diagnostic testing technology. The FDA EUA process requires novel diagnostic devices to undergo a substantial amount of complex design control and testing. All functions for critical system operation must be validated and submitted as part of the process. “The MiQLab systems we’ve sold into veterinary diagnostics and the biologics manufacturing market are in the field and working as designed. Part of our strategy is to use these systems in real-world settings, processing complex samples, to ensure our technology is ready to pass the stringent FDA requirements... we have passed electrical safety testing, passed ship testing, finalized our master mix and carrier fluid formulation, finalized our test assays and their configuration, finalized our internal amplification control and

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LexaGene advances towards FDA emergency use nod for MiQLab System